Development of a core outcome set for basal cell carcinoma - 19/08/22
Doi : 10.1016/j.jaad.2022.04.059
Daniel I. Schlessinger, MD a, b, Kelly A. Reynolds, BA a, c, McKenzie A. Dirr, BA, BS a, Sarah A. Ibrahim, MD a, Arianna F. Yanes, MD d, Jake M. Lazaroff, MD a, Victoria Godinez-Puig, MD a, Brian R. Chen, MD a, Anastasia O. Kurta, DO e, Jill K. Cotseones, DO f, Sarah G. Chiren, BA a, Karina C. Furlan, MD g, Sanjana Iyengar, MD h, Ramona Behshad, MD e, Danielle M. DeHoratius, MD i, Pablo Denes, MD, MPH j, Aaron M. Drucker, MD, ScM k, l, Leonard M. Dzubow, MD m, Jeremy R. Etzkorn, MD i, Catherine A. Harwood, PhD, FRCP n, o, John Y.S. Kim, MD p, Naomi Lawrence, MD q, Erica H. Lee, MD r, Gary S. Lissner, MD s, Ashfaq A. Marghoob, MD t, Rubeta N. Matin, PhD, MBBS, FRCP u, Adam R. Mattox, DO v, Bharat B. Mittal, MD w, J. Regan Thomas, MD x, Xiaolong Alan Zhou, MD, MSc a, David Zloty, MD y, Jochen Schmitt, MD, MPH z, Jamie J. Kirkham, PhD aa, April W. Armstrong, MD, MPH ab, Nicole Basset-Seguin, MD, PhD ac, Elizabeth M. Billingsley, MD ad, Jeremy S. Bordeaux, MD, MPH ae, Jerry Brewer, MD, MS af, Marc Brown, MD ag, Mariah Brown, MD ah, Scott A.B. Collins, MD ai, Maria Concetta Fargnoli, MD aj, Sergio Jobim De Azevedo, MD, FACP ak, Reinhard Dummer, MD al, Alexander Eggermont, MD, PhD am, Glenn D. Goldman, MD an, Merete Haedersdal, MD, DMSc, PhD ao, Elizabeth K. Hale, MD ap, Allison Hanlon, MD, PhD aq, Kelly L. Harms, MD, PhD ar, Conway C. Huang, MD as, Eva A. Hurst, MD at, Gino K. In, MD, MPH au, Nicole Kelleners-Smeets, MD PhD av, Meenal Kheterpal, MD aw, Barry Leshin, MD ax, Michel Mcdonald, MD ay, Stanley J. Miller, MD az, Alexander Miller, MD ba, Eliot N. Mostow, MD, MPH bb, Myrto Trakatelli, MD, PhD bc, Kishwer S. Nehal, MD bd, Desiree Ratner, MD be, Howard Rogers, MD, PhD bf, Kavita Y. Sarin, MD, PhD bg, Seaver L. Soon, MD bh, Thomas Stasko, MD bi, Paul A. Storrs, MD bj, Luca Tagliaferri, MD, PhD bk, Allison T. Vidimos, RPh, MD bl, Sandra L. Wong, MD, MS bm, Siegrid S. Yu, MD bn, Iris Zalaudek, MD bo, Nathalie C. Zeitouni, MDCM, FRCPC bp, John A. Zitelli, MD bq, Emily Poon, PhD a, Joseph F. Sobanko, MD d, br, Todd V. Cartee, MD bs, Ian A. Maher, MD v, Murad Alam, MD, MSCI, MBA a, x, bt, ⁎ 
a Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
b Division of Dermatology, Department of Internal Medicine, Washington University, St. Louis, Missouri
c University of Cincinnati College of Medicine, Cincinnati, Ohio
d Department of Dermatology, Perelman Center for Advanced Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
e Department of Dermatology, Saint Louis University, St. Louis, Missouri
f Medical & Cosmetic Dermatology Service, Northwestern Medicine Regional Medical Group, Naperville, Illinois
g Department of Pathology, Rush University Medical Center, Chicago, Illinois
h Department of Dermatology, West Virginia University, Morgantown, West Virginia
i Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
j Division of Cardiology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
k Division of Dermatology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada
l Division of Dermatology, Department of Medicine and Women's College Research Institute, Women's College Hospital, Toronto, Ontario, Canada
m Private Practice, Media, Pennsylvania
n Department of Dermatology, Royal London Hospital, Barts Health NHS Trust, London, United Kingdom
o Centre for Cell Biology and Cutaneous Research, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom
p Division of Plastic and Reconstructive Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
q Division of Dermatologic Surgery, Department of Dermatology, Cooper University Hospital, Camden, New Jersey
r Dermatology Service, Memorial Sloan Kettering Cancer Center, New York, New York
s Department of Ophthalmology, Northwestern University, Feinberg School of Medicine, Chicago, Illinois
t Department of Dermatology, Memorial Sloan Kettering Cancer Center, New York, New York
u Department of Dermatology, Churchill Hospital, Oxford, United Kingdom
v Department of Dermatology, University of Minnesota, Minneapolis, Minnesota
w Department of Radiation Oncology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
x Department of Otolaryngology - Head and Neck Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
y Department of Dermatology & Skin Science, University of British Columbia, Vancouver, British Columbia, Canada
z Center for Evidence-based Healthcare, Medical Faculty Carl Gustav Carus, TU Dresden, Dresden, Germany
aa Centre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom
ab Keck School of Medicine, Department of Dermatology, University of Southern California, Los Angeles, California
ac Universite de Paris, Hospital Saint Louis, Paris, France
ad Department of Dermatology, Penn State Hershey Medical Center, Hershey, Pennsylvania
ae Department of Dermatology, University Hospitals of Cleveland, Case Western Reserve University, Cleveland, Ohio
af Mayo Clinic, Rochester, Minnesota
ag Department of Dermatology and Oncology, University of Rochester, Rochester, Minnesota
ah Department of Dermatology, University of Colorado Hospital and School of Medicine, Aurora, Colorado
ai Private Practice, Dermatology Associates, Tigard, Oregon
aj Dermatology, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy
ak Department of Medicine, Chief of Medical Oncology at Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil
al University Hospital, Skin Cancer Center, Zurich, Switzerland
am University Medical Center Utrecht, The Netherlands
an University of Vermont Medical Center, Burlington, Vermont
ao Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark
ap The Ronald O. Perelman Department of Dermatology, New York University School of Medicine, New York, New York
aq Vanderbilt Department of Dermatology, Nashville, Tennessee
ar Department of Dermatology, University of Michigan Medical School, Michigan Medicine, Ann Arbor, Michigan
as Department of Dermatology, University of Alabama at Birmingham, Birmingham, Alabama
at Distinctive Dermatology, Fairview Heights, Illinois
au Division of Medical Oncology, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, California
av Maastricht University Medical Centre, Maastricht, The Netherlands
aw Duke University, Durham, North Carolina
ax Skin Surgery Center, Winston-Salem, North Carolina
ay Vanderbilt University Medical Center, Nashville, Tennessee
az Johns Hopkins Hospital, Baltimore, Maryland
ba Department of Dermatology, University of California Irvine, Irvine, California
bb Northeast Ohio Medical University (NEOMED), Rootstown, Ohio
bc Department of Dermatology, Papageorgiou Hospital, Aristotle University Department of Medicine, Thessaloniki, Greece
bd Dermatology Service, Memorial Sloan Kettering Cancer Center, New York, New York
be Dermatology, NYU Grossman School of Medicine, New York, New York
bf Advanced Dermatology, Norwich, Connecticut
bg Department of Dermatology, Stanford University School of Medicine, Stanford, California
bh The Skin Clinic MD (private practice), San Diego, California
bi Department of Dermatology, The University of Oklahoma, Oklahoma City, Oklahoma
bj Department of Dermatology, University of Illinois Chicago, Chicago, Illinois
bk Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy
bl Department of Dermatology, Cleveland Clinic, Cleveland, Ohio
bm Department of Surgery, Dartmouth Health, Lebanon, New Hampshire
bn Department of Dermatology, University of California San Francisco, California
bo Department of Dermatology and Venereology, University of Trieste, Trieste, Italy
bp Medical Dermatology Specialists, Phoenix, Arizona
bq Dermatology, Otolaryngology, and Plastic Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
br Division of Dermatologic Surgery, Department of Dermatology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
bs Department of Dermatology, Penn State Health, Milton S. Hershey Medical Center, Hershey, Pennsylvania
bt Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
∗Correspondence to: Murad Alam, MD, MSCI, MBA, Department of Dermatology, Feinberg School of Medicine, Northwestern University, 676 N St Clair Street, Suite 1600, Chicago, IL 60611.Department of DermatologyFeinberg School of MedicineNorthwestern University676 N St Clair Street, Suite 1600ChicagoIL60611
Abstract |
Background |
There is variation in the outcomes reported in clinical studies of basal cell carcinoma. This can prevent effective meta-analyses from answering important clinical questions.
Objective |
To identify a recommended minimum set of core outcomes for basal cell carcinoma clinical trials.
Methods |
Patient and professional Delphi process to cull a long list, culminating in a consensus meeting. To be provisionally accepted, outcomes needed to be deemed important (score, 7-9, with 9 being the maximum) by 70% of each stakeholder group.
Results |
Two hundred thirty-five candidate outcomes identified via a systematic literature review and survey of key stakeholders were reduced to 74 that were rated by 100 health care professionals and patients in 2 Delphi rounds. Twenty-seven outcomes were provisionally accepted. The final core set of 5 agreed-upon outcomes after the consensus meeting included complete response; persistent or serious adverse events; recurrence-free survival; quality of life; and patient satisfaction, including cosmetic outcome.
Limitations |
English-speaking patients and professionals rated outcomes extracted from English language studies.
Conclusion |
A core outcome set for basal cell carcinoma has been developed. The use of relevant measures may improve the utility of clinical research and the quality of therapeutic guidance available to clinicians.
Le texte complet de cet article est disponible en PDF.Key words : basal cell carcinoma, core, measure, outcome, set, skin cancer
Abbreviations used : BCC, COS
Plan
| Funding sources: Supported by the Merz Center for Quality and Outcomes Research in Dermatologic Surgery and the IMPROVED (Measurement of Priority Outcome Variables in Dermatologic Surgery) Group. |
|
| IRB approval status: Reviewed and approved by Northwestern University IRB (STU00097285). |
|
| Reprints not available from the authors. |
© 2022
American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
Vol 87 - N° 3
P. 573-581 - septembre 2022 Retour au numéro
Article précédent
- Melanoma with peripheral globules: Clinical and dermatoscopic features
- Ana F.A. Moraes, Tatiana C.M.P. Blumetti, Clovis Pinto, Eduardo Bertolli, Gisele Rezze, Ashfaq A. Marghoob, Juliana C.T. Braga
- Longitudinal course and predictors of depressive symptoms in atopic dermatitis
- Sheena Chatrath, Donald Lei, Muhammad Yousaf, Rajeev Chavda, Sylvie Gabriel, Jonathan I. Silverberg
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?